Spots Global Cancer Trial Database for Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions
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Trial Identification
Brief Title: Prime-boost Vaccine Study in Women With Low-grade Cervical HPV Lesions
Official Title: A Phase 1b/2, Randomised, Placebo-controlled, Dose-ranging Study to Evaluate Safety, Tolerability and Immunogenicity of a Chimpanzee Adenovirus (ChAdOx1)-Vectored Multigenotype High Risk Human Papillomavirus (hrHPV) Vaccine and Modified Vaccinia Ankara (MVA)-Vectored Multigenotype hrHPV Vaccine in Women With Low-grade HPV-related Cervical Lesions
Study ID: NCT04607850
Study Description
Brief Summary: A Phase 1b/2 multi-centre study evaluating the safety, efficacy and immunogenicity of prime-boost vaccines ChAdOx1-HPV and MVA-HPV in women with HPV related low grade cervical lesions.
Detailed Description: The study consists of an open label, non-randomised, dose escalation Lead in phase. 9 participants with high-risk HPV, in cohorts of 3 in 3 dose ascending groups, will be vaccinated after SMC safety data reviews. This is followed by a blinded, randomised Main phase with 96 participants with high-risk HPV, in parallel running dose cohorts (three different doses of ChAdOx1-HPV plus two different doses of MVA-HPV versus placebo plus placebo boost). At least 60 of these participants will take part in the immunogenicity sub-study. A blinded, randomised expansion phase investigating the effects of up to two different main phase doses against placebo will be further defined prior to commencing this phase of the study.
Keywords
Eligibility
Minimum Age: 25 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
UZA, Antwerp, , Belgium
Erasme Hospital, Brussels, , Belgium
UZ Brussel, Brussels, , Belgium
UZ Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Parnu Hospital Womens and Childrens Clinic, Parnu, , Estonia
East-Tallinn Central Hospital, Tallinn, , Estonia
North Estonia Medical Centre Foundation Surgery Clinic, Tallinn, , Estonia
Tartu University Hospital Womens Clinic, Tartu, , Estonia
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
University Hospital Bristol NHS Trust, Bristol, , United Kingdom
Liverpool Women's NHS Foundation Trust, Liverpool, , United Kingdom
Royal Victoria Infirmary, Newcastle Upon Tyne, , United Kingdom
Nottingham University Hospital NHS Trust, Nottingham, , United Kingdom
The University of Oxford, Nuffield Department of Women's & Reproductive Health, Oxford, , United Kingdom
Royal Preston Hospital, Preston, , United Kingdom
Contact Details
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